A Double-blind, Double-dummy, Randomised, Placebo-controlled, 4-way, Crossover, Multi-centre Phase II Study With Budesonide as an Active Control to Evaluate the Efficacy and Safety of 2 Doses of Inhaled AZD5423 Over 7 Days in Patients With Mild Allergic Asthma Challenged With an Inhaled Allergen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •Pre-bronchodilatory FEV1 ≥70% of predicted normal allergic asthmatic with a history of episodic wheeze
- •Positive allergen induced early and late airway bronchoconstriction showing ≥ 20% fall in FEV1 for the early and ≥ 15% for the late response
- •Positive skin prick test to common aeroallergens
排除标准
- •Any clinically significant disease or disorder
- •Any clinically relevant abnormal finding at screening examinations
- •Smoker or ex-smoker who has stopped smoking < 12 months prior to study start
- •Worsening of asthma or respiratory infection within 6 weeks from visit 1
- •Allergen-specific immunotherapy within 6 months prior to visit 1
研究组 & 干预措施
1
AZD5423 75ug
干预措施: AZD5423 (Drug)
1
AZD5423 75ug
干预措施: Placebo (Drug)
2
AZD5423 300ug
干预措施: AZD5423 (Drug)
2
AZD5423 300ug
干预措施: Placebo (Drug)
3
Budesonide 200 microgram
干预措施: Budesonide 200 microgram (Drug)
3
Budesonide 200 microgram
干预措施: Placebo (Drug)
4
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Late Allergic Response (LAR) by Assessment of Minimum Percentage of FEV1 3-7 Hours Post Allergen Challenge Compared to Pre Allergen Challenge FEV1
时间窗: From Randomization to end of treatment
LAR was assessed on Day 6 as minimum percentage of FEV1 over 3 to 7 hours based on the analysis of the minimum percentage of FEV1 remaining over 3 to 7 hours post allergen challenge (post AC) compared to pre allergen challenge (pre AC) FEV1
次要结局
- Early Allergic Response (EAR) by Assessment of Minimum Percentage of FEV1 0-3 h Post Allergen Challenge(From Randomization to end of treatment)
- Changes in Sputum Eosinophils Differentials (Percentage)(Day 7 ([post dose] 24 hours post allergen challenge))
- Airway Hyperresponsiveness by Assessment of Methacholine PC20(Day 7 ([post-dose] 24 hours post allergen challenge))
- Area Under the Curve (AUC) for FEV1 Over 0-3 and 3-7 h Post Allergen Challenge(From Randomization to end of treatment)